Self-sealing male luer connector with multiple seats

ABSTRACT

A self-sealing male Luer connector attaches to any standard female Luer valve to open a flow channel between the two. The self-sealing male Luer connector includes a rigid housing having a distal end with a rigid male Luer connector and a proximal end at which a proximal seal is formed. The distal end of the housing includes a valve seat. Located within the housing is a resilient biasing member that biases an actuator into contact with the valve seat to prevent fluid flow through the male connector. Upon engagement with a female connector, the actuator is moved in the proximal direction to open the distal valve and then the proximal seal. A partial vacuum is formed within the male connector upon disengagement with the female connector that draws any fluids on the external surface of the distal end of the male Luer connector into the male tip.

BACKGROUND OF THE INVENTION

The invention relates generally to male connectors that allow for thepassage of fluid once connected, and more particularly, to aself-sealing male connector having an internal valve structure that isautomatically actuated to permit flow once properly connected to afemale connector.

The self-sealing medical connectors presently known and used in the artare generally designed to be connected to a patient's intravenous (“IV”)or gas sampling line, drug or solution source, or other medical devicesuch that the connector's seal operates to trap all fluid on the side ofthe connector toward the patient or other device. As such, the typicalconnector has an unsealed male Luer connector on one end that remainsconnected to the patient's I.V. line, fluid source or other device and aself-sealing female connector on the opposite free end of the connectorthrough which a syringe or other such device may be engaged. Theself-sealing female connector typically has an internal valve that isopened upon connection with a male connector and which automaticallycloses upon disconnection from the male connector.

In use, the syringe or other device having a male connector is connectedto the female end of the connector to push or pull fluids through thefemale connector, as when medications are dispensed within a patient'sI.V. line. The syringe or other device is configured with a maleconnector so as to engage the self-sealing female connector and causethe male connector's central boss to contact the female connector's sealmembrane, opening the internal valve of the female connector andcreating a fluid path through the female connector. After the necessaryfluids have been dispensed or withdrawn, the syringe is removed and theinternal valve in the female needle-free connector closes to reseal thefemale connector and trap all bodily fluids, including anyjust-dispensed medications, on the patient side of the connector.However, the male connector of the syringe typically does not include aninternal valve and any residual fluids remaining therein are unsealedand exposed.

In the medical industry, there are applications in which the fluid beingdispensed from or drawn into the syringe or other device or containermust itself be at all times sealed off and exposure of the care giver tosuch fluid prevented or at least minimized. For example, in the area ofnuclear medicine where radioactive isotopes are administered topatients, it is critical that exposure to the isotopes be minimized forthe safety of both the care giver and the patient. A further exampleincludes collecting blood from a patient, were it is important toprevent exposure of the blood remaining in the collection device to thecare giver.

Yet a further example is in the oncology area where certain drugs havegreat beneficial effect when confined to the circulatory system of apatient, yet are harmful to the skin or other tissues of a patient. Suchdrugs must be carefully controlled so that they do not reach tissuesthat may be harmed. Transferring such drugs from one container toanother or to the patient's fluid line can be hazardous if seals are notpresent.

For these purposes, a different self-sealing, needle-free male Luerconnector design is desirable. Where even the slightest amount ofcontact between such strong medical fluids and the clinician or thepatient's outer tissue is to be avoided, it would be highly beneficialto provide a male connector that is able to minimize the existence ofsuch fluids on its outer surfaces. In the case where such fluidsinadvertently reside on such outer surfaces, such a connector shouldprovide a means of removing the fluids form those surfaces.

It is becoming more and more common for connectors to use Luer shapes.This is because an international standard has been adopted for suchshapes; see ISO No. 594. Such Luer shapes have a tapered outer surfacefor male connectors and a complementary tapered inner surface for femaleconnectors. Such tapering permits connectors having less precisedimensions to still successfully mate for fluid transfer. For moresecure connection, threads or thread elements have been added to theouter surface surrounding the female connector's opening and a threadedcollar has been added about the male Luer connector. The threaded collarmay freely rotate or may be fixed in position about the male Luerconnector. Because of the wide availability of female connectors andfemale valve ports, it would be desirable to provide a self-sealing maleconnector having a Luer shape.

Hence, those skilled in the art have recognized a need for aself-sealing male connector to seal off residual fluids therein beforeand after connection to a female connector. Such a self-sealing maleconnector may be connected to or formed as part of a syringe or otherdevice, or formed on a blood collection device, or may be used withtubing or other devices for controllably conducting medical fluids,including more dangerous fluids that are toxic or corrosive. Anadditional need has been recognized for a self-sealing male connectorthat also self cleans its outer surfaces. The present invention fulfillsthese needs and others.

SUMMARY OF THE INVENTION

Briefly and in general terms, the invention is directed to aself-sealing male connector for connection with a female connector, themale connector comprising a rigid housing having a distal end and aproximal end, the housing comprising at the distal end a rigid tubularmale portion having a shape selected for engagement with a femaleconnector, a distal valve located at the distal end of the housing, thedistal valve comprising an internal valve seat disposed in the tubularmale portion, a proximal valve located at the proximal end of thehousing, and a rigid actuator movably disposed within the housing formovement toward the proximal end of the housing to open both the distaland proximal valves, the actuator comprising a rigid actuator armdisposed adjacent and outside the tubular male portion wherein movementof the actuator arm towards the proximal end of the housing will causethe actuator to move towards the proximal end of the housing and openboth the distal and proximal valves, whereby as a female connector isengaged with the tubular male portion, the female connector will movethe actuator arm towards the proximal end of the housing thereby openingboth the distal and proximal valves.

In more detailed aspects, the connector further comprises a resilientmember contained within the housing and positioned to bias the actuatortowards the distal end of the housing to close both the distal andproximal valves. Further, the proximal valve comprises a proximal sealdisposed at the proximal end of the housing, the seal being formed as aseptum. In another aspect, the septum is connected to the resilientmember.

In other aspects, the actuator comprises a distal end and a proximalend, the proximal end comprising a piercing element located so at topierce the proximal valve upon movement of the actuator in the proximaldirection. Further, the piercing element includes a lumen through whichfluid may flow. In another aspect, the piercing element includes alongitudinal slot through which fluid may flow. The distal end of theactuator comprises a valve stem within which a fluid flow lumen isdisposed. The actuator further comprises a tip seal located at a distalend of the valve stem, which, when the actuator is in a distal positionwithin the housing, closes the distal valve to prevent the flow of fluidthrough the distal valve. The actuator further comprises an orifice at adistal end of the valve stem, the orifice disposed in fluidcommunication with a lumen of the valve stem to form a fluid flowchannel through the actuator. The orifice is formed through alongitudinal wall surrounding the valve stem lumen.

In yet further detailed aspects of the invention, the connector furthercomprising a hollow resilient member contained within the housing andpositioned to bias the actuator towards the distal end of the housing toclose both the distal and proximal valves, a hollow portion of theresilient member being disposed in fluid communication with the lumen ofthe valve stem to provide a flow channel between the distal valve andthe proximal valve. The piercing member is disposed on the actuator sothat as the actuator moves in the proximal direction, the distal valveopens before the proximal valve opens. In another aspect, the piercingmember is disposed on the actuator so that as the actuator moves in thedistal direction, the proximal valve closes before the distal valvecloses.

In still further detailed aspects, the actuator comprises a valve stemlocated within the tubular male portion, the valve stem having a tipseal forming a part of the first valve wherein the tip seal is locatedat a distal end of the valve stem which, when the actuator is in thedistal position, closes the first valve to prevent the flow of fluidthrough the first valve, a lumen formed in the valve stem through whichfluid may flow, an orifice formed at the distal end of the valve stemthrough which fluid may flow into and out of the lumen, and a slidingseal located between an external surface of the valve stem and engagingan inner surface of the male portion proximal to the orifice so as toprovide a fluid seal between the male Luer portion and the valve stem.

In another aspect, the actuator is formed so that as it moves in thedistal direction, it closes the distal valve and proximal valvesequentially to result in a partial vacuum being formed at the male Luerportion opening to draw fluid into the male Luer portion. Further, aflow channel is disposed through the tubular male portion, the distalvalve, the actuator, and the proximal valve.

In additional aspects of the invention, a self-sealing male Luerconnector is provided for connection with a female Luer connector, themale Luer connector comprising a rigid housing having a distal end and aproximal end, the housing comprising at the distal end a rigid tubularmale Luer portion having a shape selected for engagement with a femaleLuer connector, a distal valve located at the distal end of the housing,the distal valve comprising an internal valve seat disposed in thetubular male Luer portion. a proximal valve located at the proximal endof the housing, a rigid actuator movably disposed within the housing formovement toward the proximal end of the housing to open both the distaland proximal valves, the actuator comprising a distal end having a valvestem within which a fluid flow lumen is disposed, and a tip seal locatedat a distal end of the valve stem, which, when the actuator is in adistal position, closes the first valve to prevent the flow of fluidthrough the first valve, and wherein the actuator further comprises arigid actuator arm disposed adjacent and outside the tubular maleportion wherein movement of the actuator arm towards the proximal end ofthe housing will cause the actuator to move towards the proximal end ofthe housing and open both the distal and proximal valves, and aresilient member contained within the housing and positioned to bias theactuator towards the distal end of the housing to close both the distaland proximal valves, whereby as a female connector is engaged with themale Luer portion, the female connector will move the actuator armtowards the proximal end of the housing thereby opening both the distaland proximal valves.

Also in accordance with method aspects of the invention, there isprovided a method of engaging a male connector with a female connector,comprising inserting a tubular male portion of the male connector intothe female connector, the male connector having a distal end at whichthe male portion is located and a proximal end, moving an actuatorpositioned within the tubular male portion in a proximal direction asthe male portion and female connector are engaged, opening a distalvalve located at the distal end of the male connector and a proximalvalve located at the proximal end of the male connector with theactuator as the actuator is being moved in the proximal direction,disengaging the tubular male portion of the male connector from thefemale connector, moving the actuator in a distal direction as the maleportion and female connector are disengaged, and closing the proximaland distal valves as the actuator is being moved in the proximaldirection.

In further detailed method aspects, the method further comprises thestep of piercing a proximal seal that forms the proximal valve with apiercing element that forms a part of the actuator. The step of openingthe distal and proximal valves comprises opening first the proximalvalve and then opening the distal valve. The step of closing theproximal and distal valves comprises closing first the proximal valveand then closing the distal valve.

In yet other detailed method aspects of the invention, the step ofclosing the proximal and distal valves comprises closing first theproximal valve, producing within the housing a partial vacuum at thedistal end of the housing, drawing fluid residing on an outer distalsurface of the housing into the housing with the partial vacuum, andthen closing the distal valve. The step of producing the partial vacuumcomprises allowing an internal resilient member to bias the actuatortoward the distal end of the housing thereby increasing the volumeinside the resilient member as such movement of the actuator toward thedistal end occurs thereby creating the partial vacuum within the housingto draw fluid into the housing.

These and other advantages of the invention will become apparent fromthe following more detailed description when taken in conjunction withthe accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of a self-sealing male Luer connectorin accordance with aspects of the invention;

FIG. 2 depicts a side elevation view of the male Luer connector shown inFIG. 1;

FIG. 3 is an exploded view of the components that form the self-sealingmale Luer connector of FIGS. 1 and 2;

FIG. 4 depicts a cross-sectional view of the self-sealing male Luerconnector taken along line A-A of FIG. 2 in an unactuated state;

FIG. 5 depicts a cross-sectional view of the self-sealing male Luerconnector taken along line A-A of FIG. 2 engaged with a female Luerconnector thus placing the male connector in an actuated state;

FIG. 6 depicts a cross-sectional view of another embodiment of aself-sealing male Luer connector in accordance with aspects of theinvention in an un-actuated state wherein the male connector includes apiercing element as part of an actuator;

FIG. 7 depicts a cross-sectional view of the self-sealing male Luerconnector of FIG. 6 engaged with a female connector and thereby in theactuated state;

FIG. 8 depicts a side-elevation view of one embodiment of an actuatorused in a self-sealing male connector in accordance with aspects of theinvention, wherein the actuator is used to open internal valves of themale connector;

FIG. 9 depicts a side-elevation view of the actuator shown in FIG. 8rotated 90 degrees;

FIG. 10 depicts a cross-sectional view of the actuator shown in FIGS. 8and 9; and

FIG. 11 depicts a top planar view of the actuator shown in FIG. 8 inwhich the actuator has four actuator arms.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in more detail for purposes ofillustration, wherein like reference numerals designate corresponding orlike elements among the several views, there is shown in FIGS. 1 and 2,a self-sealing male Luer connector 10 in accordance with one embodimentof the present invention. The self-sealing male Luer connector isintended to engage a standard female Luer connector. The female Luerconnector is not limited to a particular type.

In this embodiment, the male Luer connector 10 includes a housing 12having a proximal end 14 and a distal end 16, at which a femaleconnector may be engaged. The housing may have a generally cylindricalshape as shown and terminate at the proximal end in a connector of sometype, or other mounting configuration for connection to another fluidflow device, such as tubing. As shown in FIGS. 1 and 2, in this case theproximal end 14 of the housing 12 has mounted to it a female adapter 18for connection with various male devices or containers. External threads20 are shown positioned about the female adapter for engagement withthreads located on a complementary male connector. The female adaptermay be designed to have a standard ANSI-HIMA female Luer taper withstandard sizes of opening, length, and thread size, although in otherembodiments, the female adapter may take other shapes and sizes.

At the distal end 16, the self-sealing male Luer connector device 10also includes a male Luer portion 22 that projects in the distaldirection from within the housing 12. The male Luer portion may also beof the standard ANSI-HIMA male Luer taper with standard outer diameterand length, although in other embodiments, the male Luer portion 22 maytake other shapes and sizes. The male Luer portion has a distal end 24at which is formed a distal fluid flow opening 26 through which fluidmay flow into and out of the self-sealing male Luer connector device 10.Also see in FIG. 1 are two actuator arms 28 that function to open aninternal valve or valves upon engagement with a female connector.Although two actuator arms are shown, in other embodiments, fewer ormore actuator arms may be used. The actuator arms in FIG. 1 areevenly-spaced about the male Luer portion with spaces or gaps 30 betweenthem.

Now referring to FIG. 3, an exploded view of the self-sealing male Luerdevice 10 of FIGS. 1 and 2 is shown. The female adapter 18 has beenseparated from the housing 12 and a flow channel 32 formed through itcan be seen. The female adapter includes mounting features to accept thehousing and an internal resilient biasing device 34, but such featuresare within the skill of those in the art and no further description willbe provided at this point. An actuator 36 includes the actuator arms 28shown in FIG. 1, although four arms are shown in this figure. Theactuator includes a valve stem 38 that interacts with a valve seat inthe housing, which will be described in further detail below and shownin other figures. The valve stem has a distal end 40 at which is mounteda tip seal 42 for closing the valve created by the valve stem and avalve seat, as will be described later. Also, the valve stem includes afluid flow orifice 44 into which and out of which fluid may flow throughthe hollow valve stem. The actuator includes a base 46 from which theactuator arms extend in the distal direction, and although not visiblein this figure, a mounting groove for accepting and containing thedistal end 48 of the resilient biasing device. Lastly, the actuatorincludes a proximally extending piercing element 50 which is useful toopen a flow passage through a septum forming a part of the resilientbiasing device at its proximal end 52, although the septum cannot beseen in this figure.

The housing 12 is also shown with the male Luer portion 22 shownprotruding in the distal direction from the cylindrical housing. Thedistal end 24 of the male Luer portion includes the fluid opening 26through which fluid may flow into and out of the self-sealing male Luerconnector 10. The actuator arms 28 from the actuator 36 will be disposedin the space 54 between the male Luer portion and the cylindricalhousing portion, as will the female Luer connector when mounted to theself-sealing male Luer connector 10.

Referring now to FIG. 4, the components shown in FIG. 3 have beenassembled into the self-sealing Luer connector 10 of FIGS. 1 and 2 and across-section view of the assembled connector device taken along lines4-4 of FIG. 2 is shown. The actuator 36 is positioned within the housingand includes the base section 46 from which the actuator arms 28 extendin the distal direction. The actuator includes a distal end 40 and aproximal end 56, and a fluid flow channel 58 located longitudinallythrough the actuator. The valve stem 38 extends in the distal directionfrom the base 46 and the flow channel is formed through the valve stem.At the distal end of the male Luer portion 22, a distal valve 59 isformed. In this embodiment, the valve tip seal 42 mounted at the distalend 40 of the valve stem forms a part of the distal valve. At the distalend is also formed an orifice 44 that interconnects with the internallongitudinal fluid flow channel 58. In the present embodiment, theaperture comprises a through hole that extends completely through thedistal end of the actuator tube radially such that there are two holesformed through opposite sides of the cylindrical wall of the valve stem,although in another embodiment, it is possible that only one hole isformed through the wall of the valve stem. The size and shape of theorifice may be varied to optimize fluid flow rates and reduce turbulenceof flow through the male device.

The proximal end 56 of the actuator includes a piercing element 50. Inthe embodiment shown in FIG. 4, the piercing element includes a bluntend 62 that may be tapered or rounded. An aperture 64 is disposed at theblunt end of the piercing element so that fluid may enter thelongitudinal flow channel 58. The piercing element may also include aspike 66 as shown in FIGS. 6 and 7. In this embodiment, there is atleast one longitudinal slot 68 formed in the wall of the actuatorextending to its proximal end. The slot helps to ensure that all fluidsand gases contained within the resilient member can easily flow into andout of the actuator both during use and when disconnecting the matingcomponent. Although it cannot be seen in this view because it is across-section, there are two longitudinal slots located opposite eachother in the wall of the actuator. In other embodiments the actuator maynot include a slot.

The valve stem 38 of the actuator 36 includes the tip seal 42 at itsdistal end for sealing engagement with a valve seat 70 formed internallyat the distal end 24 of the male Luer portion 22. The valve seat 70, tipseal 42, and valve stem 38 form the distal valve 59 in this embodiment.In one embodiment there is also a sliding seal 72 disposed at the distalend 40 of the actuator 36 as well. The sliding seal is disposedproximally from the orifice 44 in the valve stem 38, so that theaperture is between the tip seal 42 and the sliding seal 72. The slidingseal prevents fluid from escaping between the outer wall 74 of theactuator and the inner wall 76 of the male Luer portion 22. Both the tipseal and the sliding seal may be joined together, and in otherembodiments the seals may be separate. The combined seals can be createdby over molding a soft, thermoplastic elastomer onto the hard plastic ofthe valve stem of the actuator, allowing the seals and actuator to bemolded together. This reduces the number of required components andeliminates the need to join the tip seal and the sliding seal to theactuator as a separate manufacturing step. This “joined” design ispresented in FIG. 8. The tip seal can be a poppet valve and the slidingseal can be a dynamic O-ring seal. It has also been contemplated thatthe tip seal and the sliding seal could be separately molded orotherwise formed from a soft, compliant material, and press fit orjoined to the first end of the actuator.

Referring again to FIG. 4, the resilient member 34 is contained withinthe housing 12 and includes a distal end 78 that abuts the actuator 36at the proximal end 56 of the actuator. In one embodiment the resilientmember fits within a groove 80 formed in the base 46 of the actuator.The proximal end 52 of the resilient member is secured to the proximalend 14 of the housing by being clamped between the housing and theadapter 18. In this embodiment the resilient member is a cylindricalflexible spring formed of silicone that also acts as a seal to containfluid within the housing. The resilient member or spring is positionedwithin the housing in a slightly compressed state to continually biasthe actuator toward the distal end 16 of the housing. This biasing forcecreates a tight seal between the tip seal 42 and the valve seat 70.However, in another embodiment, it may be possible that the resilientmember is installed within the housing such that it is uncompressed whenthe self-sealing male Luer connector 10 is in its non-actuated state.

While the resilient member 34 or silicone spring is shown as anaccordion shaped member, it could be made in several otherconfigurations, including an elongated O-ring shape. Further, the shapeand the thickness of the resilient member can be changed to increase ordecrease both the spring or biasing force that the resilient membergenerates, as well as the internal volume change it generates between acompressed state (FIG. 5) and an extended state (FIG. 4).

In the embodiment shown in FIG. 4, the self-sealing male Luer connector10 further includes a proximal valve 81 located at the proximal end ofthe housing 12. A proximal seal 82 in the form of a septum in thisembodiment is disposed at the proximal end 14 of the housing 12 to sealagainst fluid or air pressures applied to the self-sealing male Luerconnector 10 from the proximal end of the housing. A slit 84 is createdin the proximal seal in the embodiment shown, although in otherembodiments, no slit may be pre-formed in the proximal seal or only apartial slit may be formed. The proximal seal may be a check-valve sealas shown in FIG. 4 or in some embodiments may be a duck-bill check valvesuch as that shown in FIGS. 6 and 7. In one embodiment the proximal sealis formed as part of the resilient member 34, or they are otherwisejoined together. The proximal seal and the resilient member may becreated by molding a soft, thermoplastic elastomer to form one componentwithout having to mechanically join the resilient member to the proximalseal. The shape of the proximal seal, its thickness, and the slit can bechanged to optimize seal pressure and the ease with which the proximalseal opens when contacted by the piercing element 50 of the actuator.

It can therefore be seen from FIG. 4 that a flow channel existscompletely through the male connector 10. At the distal end, the flowchannel begins at the distal tip 24 of the male Luer portion through theopening 26, proceeds through the distal valve 59, through the orifice 44of the valve stem 38, through the lumen 58 of the valve stem 38, throughthe proximal valve 81, through the aperture 64 of the piercing element50, and through the flow channel 32 of the female adapter 18.

Referring now to FIG. 5, the self-sealing male Luer connector 10 isshown engaged with a standard female Luer connector 86, such that themale Luer device is in an actuated state. As the female connector isthreaded onto the male Luer connector, the front surface 88 of thefemale connector comes into contact with the actuator arms 28 of theactuator 36 and moves the actuator in the proximal direction. Thismovement also moves the tip seal 42 of the valve stem 38 of the actuatorin the proximal direction away from the valve seat 70, thereby openingthe distal orifice 26 for the flow of fluid. The movement of theactuator in the proximal direction collapses the resilient member 34 andforces the blunt end 62 of the piercing element 50 through the slit 84of the proximal seal 82 thereby opening this seal to allow the flow offluid through the proximal end of the housing. In this fully actuatedstate, the tip seal and the proximal seal are open, allowingbi-directional fluid flow through the self-sealing male Luer connector.As fluid flows through the male connector, the sliding seal 72 preventsfluid from escaping between the outer wall 74 of the actuator 36 and theinner wall 76 of the male Luer portion 22. In one embodiment, thedimensions of the actuator are such that the tip seal on the valve stemis removed from the valve seat at the distal end 40 of the male Luerportion before the piercing element passes through and opens theproximal seal.

When fluid is transferred through the self-sealing male Luer connector10 and into the female Luer connector 86, the flow path through the maleLuer device includes flowing into the aperture 64 on the piercingelement 58 of the actuator 36. The fluid then flows through the lumen 58of the actuator and exits the actuator via the distal orifice 44 locatednear the distal end 40 of the actuator. Fluid continues to flow from theorifice of the valve stem to the lumen 90 formed by the male Luerportion and out through the distal opening 26 of the male Luer portionand into the female Luer connector. This flow path is reversed whenfluid is transferred from the female Luer connector to the male Luerdevice.

As the female Luer connector 86 is removed from the self-sealing maleLuer connector 10, the actions described above occur in reverse as theactuator 36 is forced to move in the distal direction toward the distalend 16 of the housing 12 by the resilient member 34. The dimensions ofthe actuator are such that the slit 84 in the proximal seal 82 closesbefore the tip seal 42 is securely pressed in a sealing relationshipagainst the valve seat 70. As the resilient member or silicone springextends itself from a compressed position to an extended position, thevolume of space 92 inside the resilient member increases, and becausethe proximal seal closes before the tip seal closes at the distal end, apartial vacuum is created in the flow path 58 that will be directedtoward the unsealed distal end 24 of the male Luer portion 22. Any fluidremaining near the distal opening 26 of the male Luer portion will bedrawn into the male Luer portion by this partial vacuum before thedistal opening is finally sealed by the tip seal 42.

Referring to FIGS. 6 and 7, another embodiment of the self-sealing maleLuer connector 10 in accordance with aspects of the invention is shown.FIG. 6 shows the self-sealing male Luer connector in the non-actuatedstate, and the male connector 10 shown is very similar to the device ofFIG. 4. In this embodiment, however, the piercing element 102 includes aspike 66 at the proximal end 104 of the actuator 106. Also, thisembodiment includes a proximal seal 108 that includes a duck-bill 110for sealing against greater reverse pressure. Another difference betweenthis embodiment and the embodiment shown in FIG. 4 is that no slit isformed in the proximal seal, or only a partial slit; that is, a slitformed through a part of the duck bill structure instead of all the waythrough. The latter construction is shown in FIG. 6. Aperture 114 in thespike forms a part of the flow lumen 58 through the actuator of theself-sealing male Luer connector. Other than the changes to the actuatorand the proximal seal, the self-sealing male Luer connector of FIGS. 6and 7 is the same as the male connector of FIGS. 1 through 5.

It can be noted in FIGS. 4, 5, 6, and 7, that the distal end 16 of thehousing contains internal threads 116. These threads are used to engagethe external threads of a female connector, as shown in FIGS. 5 and 7 sothat the two connectors are more securely held together. Although thehousing 12 and internal threads 116 are integral, other embodiments maybe formed. For example, the housing may be formed so as to have a freelyrotating distal section within which the threads are formed. This theneffectively results in a threaded collar and with such a design, onlythe collar need be rotated to lock the female connector to the maleconnector. Otherwise, either the female or male connector must berotated in its entirety in relation to the other connector to achievethreaded engagement.

FIG. 7 shows the self-sealing male Luer connector 10 engaged with thefemale Luer connector 86 and the arrows show the fluid path through themale connector and the female connector. In this actuated state, fluidis forced to flow through the aperture 114 of the spike 66 and throughthe lumen 58 of actuator 36. The fluid then flows out of the orifice 44on both sides of the actuator, forming a T-shaped junction in the flowpath 58. Once out of the actuator, the fluid flows through the lumen 90of the male Luer portion 22 and then out through the distal opening 26of the male Luer portion and into the female Luer connector. It ispossible to modify the shape of the T-shaped junction in the flow pathto optimize fluid flow rates and to reduce turbulence of flow bychanging the size, shape, and position of the through hole.

FIGS. 8-11 show the actuator 106 of the self-sealing male Luer connector10 of FIGS. 6 and 7 in greater detail. Other than the proximal end 104of the actuator 106, the actuator shown is also very similar to theembodiment of the actuator shown in FIGS. 3 and 4 that includes a bluntend and a slot. FIG. 8 is a side elevation view of the actuatorincluding the actuator arms 28 separated by gaps 118. As shown in FIG.11, which is a top planar view of the actuator, this particularembodiment includes four evenly-spaced actuator arms 28 that extend fromthe base section 46. It can be noted from a study of FIGS. 4 through 7that the male Luer portion 22 is formed as a part of the housing. Themale Luer portion is coaxially located partially within the housing bymeans of struts 120 between it and the inside surface of the housing.The number of struts matches the number of gaps between the actuatorarms. During assembly of the actuator with the housing, the actuator isrotated so that its arms are positioned between the struts that suspendthe male Luer portion within the housing.

In the embodiment shown in FIG. 9, the orifice 44 is best shown disposedat the distal end of the actuator. The orifice extends through the firstend of the valve stem 38 such that there are two holes formed throughthe cylindrical wall of the valve stem on opposite sides as shown inFIG. 10, although it is possible that only one aperture is formedthrough the wall of the actuator. Also the aperture 114 of the spike 66is shown in FIGS. 8, 9, and 10.

It should be understood that the use of the terms “distal” and“proximal” is meant as a reference to direction and not as limiting onthe invention. As an example of the materials selected for theembodiments shown, the housing 12 was formed of a rigid polycarbonate,the actuator 36 was formed of a rigid polypropylene, the resilientmember 34 was formed of a resilient material such as silicone, and thefemale adapter 18 was formed of a rigid polycarbonate. The tip seal 42and the sliding seal 72 were formed of a resilient material known asthermoplastic elastomer. Because the proximal seal 82 was formed as partof the resilient member, it too was formed of the resilient silicone.This is beneficial in that it is desirable for the proximal seal toreturn to its original position and sealed configuration upon withdrawalof the piercing element 50. The self-sealing male Luer connector 10 maythen be accessed multiple times.

Although exemplary embodiments of the invention have been describedabove by way of example only, it will be understood by those skilled inthe field that modifications may be made to the disclosed embodimentswithout departing from the scope of the invention, which is defined bythe appended claims.

1. A self-sealing male connector for connection with a female connector,the male connector comprising: a rigid housing having a distal end and aproximal end, the housing comprising at the distal end a rigid tubularmale portion having a shape selected for engagement with a femaleconnector; a distal valve located at the distal end of the housing, thedistal valve comprising an internal valve seat disposed in the tubularmale portion; a proximal valve located at the proximal end of thehousing; a rigid actuator movably disposed within the housing formovement toward the proximal end of the housing to open both the distaland proximal valves, the actuator comprising a rigid actuator armdisposed adjacent and wholly outside the tubular male portion andextending axially in a proximal to distal direction wherein movement ofthe actuator arm towards the proximal end of the housing will cause theactuator to move towards the proximal end of the housing and open boththe distal and proximal valves; whereby as a female connector is engagedwith the tubular male portion, the female connector will move theactuator arm towards the proximal end of the housing thereby openingboth the distal and proximal valves and wherein the actuator comprises adistal end and a proximal end, the proximal end comprising a piercingelement located so at to pierce the proximal valve upon movement of theactuator in the proximal direction.
 2. The connector of claim 1 whereinthe distal end of the actuator comprises a valve stem within which afluid flow lumen is disposed.
 3. The connector of claim 2 wherein theactuator further comprises an orifice at a distal end of the valve stem,the orifice disposed in fluid communication with a lumen of the valvestem to form a fluid flow channel through the actuator.
 4. The connectorof claim 3 wherein the orifice is formed through a longitudinal wallsurrounding the valve stem lumen.
 5. The connector of claim 3 furthercomprising a hollow resilient member contained within the housing andpositioned to bias the actuator towards the distal end of the housing toclose both the distal and proximal valves, a hollow portion of theresilient member being disposed in fluid communication with the lumen ofthe valve stem to provide a flow channel between the distal valve andthe proximal valve.
 6. The connector of claim 2 wherein the actuatorfurther comprises a tip seal located at a distal end of the valve stem,which, when the actuator is in a distal position within the housing,closes the distal valve to prevent the flow of fluid through the distalvalve.
 7. The connector of claim 1 further comprising a resilient membercontained within the housing and positioned to bias the actuator towardsthe distal end of the housing to close both the distal and proximalvalves.
 8. The connector of claim 7 wherein the proximal valve comprisesa proximal seal disposed at the proximal end of the housing, the sealbeing formed as a septum.
 9. The connector of claim 8 wherein the septumis connected to the resilient member.
 10. The connector of claim 1wherein the piercing element includes a lumen through which fluid mayflow.
 11. The connector of claim 10 wherein the piercing elementincludes a longitudinal slot through which fluid may flow.
 12. Theconnector of claim 1 wherein the piercing member is disposed on theactuator so that as the actuator moves in the proximal direction, thedistal valve opens before the proximal valve opens.
 13. The connector ofclaim 1 wherein the piercing member is disposed on the actuator so thatas the actuator moves in the distal direction, the proximal valve closesbefore the distal valve closes.
 14. The connector of claim 1 wherein theactuator comprises: a valve stem located within the tubular maleportion, the valve stem having a tip seal forming a part of the firstvalve wherein the tip seal is located at a distal end of the valve stemwhich, when the actuator is in the distal position, closes the firstvalve to prevent the flow of fluid through the first valve; a lumenformed in the valve stem through which fluid may flow; an orifice formedat the distal end of the valve stem through which fluid may flow intoand out of the lumen; and a sliding seal located between an externalsurface of the valve stem and engaging an inner surface of the maleportion proximal to the orifice so as to provide a fluid seal betweenthe male Luer portion and the valve stem.
 15. The connector of claim 1wherein the actuator is formed so that as it moves in the distaldirection, it closes the proximal valve and distal valve sequentially toresult in a partial vacuum being formed at the male Luer portion openingto draw fluid into the male Luer portion.
 16. The connector of claim 1comprising a flow channel disposed through the tubular male portion, thedistal valve, the actuator, and the proximal valve.
 17. A self-sealingmale Luer connector for connection with a female Luer connector, themale Luer connector comprising: a rigid housing having a distal end anda proximal end, the housing comprising at the distal end a rigid tubularmale Luer portion having a shape selected for engagement with a femaleLuer connector; a distal valve located at the distal end of the housing,the distal valve comprising an internal valve seat disposed in thetubular male Luer portion; a proximal valve located at the proximal endof the housing; a rigid actuator movably disposed within the housing formovement toward the proximal end of the housing to open both the distaland proximal valves, the actuator comprising a distal end having a valvestem within which a fluid flow lumen is disposed, and a tip seal locatedat a distal end of the valve stem, which, when the actuator is in adistal position, closes the first valve to prevent the flow of fluidthrough the first valve, and wherein the actuator further comprises arigid actuator arm disposed adjacent and wholly outside the tubular maleportion and extending axially in the proximal to distal direction,wherein movement of the actuator arm towards the proximal end of thehousing will cause the actuator to move towards the proximal end of thehousing and open both the distal and proximal valves; a resilient membercontained within the housing and positioned to bias the actuator towardsthe distal end of the housing to close both the distal and proximalvalves; whereby as a female connector is engaged with the male Luerportion, the female connector will move the actuator arm towards theproximal end of the housing thereby opening both the distal and proximalvalves and wherein the actuator comprises a distal end and a proximalend, the proximal end comprising a piercing element located so at topierce the proximal valve upon movement of the actuator in the proximaldirection.
 18. The connector of claim 17 wherein the actuator furthercomprises an orifice at the distal end of the valve stem, the orificebeing formed through a longitudinal wall surrounding the valve stemlumen to thereby be in fluid communication with the lumen of the valvestem to form a fluid flow channel through the actuator.
 19. Theconnector of claim 18 wherein the actuator is shaped so that as theactuator moves in the proximal direction, the distal valve opens beforethe proximal valve opens and so that as the actuator moves in the distaldirection, the proximal valve closes before the distal valve closes. 20.The connector of claim 18 further comprising a sliding seal locatedbetween an external surface of the valve stem and an inner surface ofthe male Luer portion at a location proximal to the orifice so as toprovide a fluid seal between the male Luer portion and the valve stem.